A Study of Package Insert Analysis of Available Drugs in Local Market

Abstract

Context: The primary source of drug information is a Package Insert (PI) which is accurate and reliable. In India, the package insert is governed by the ‘Drugs and Cosmetics Act (1940) and Rules (1945). The section 1 of Schedule Y of the rules lists the headings according to which information should be provided in the PIs. Aim: This study was undertaken to assess the completeness of information provided in PIs available in local pharmacies. Settings and Design: A prospective observational study was conducted from September 2023 to November 2023. Total 100 package inserts were taken in this study and they were collected from pharmacies located in various parts of Rajkot city. Methods and Material: 100 package inserts were analyzed based on 16 criteria mentioned in the Indian Drugs and Cosmetics Act (1940) and Rules (1945), under section 1 of schedule Y. Results: Only 5 PIs had all 16 criteria. 31% of PIs lacked information about Incompatibility, List of excipients, Instruction for Handling and about containers. 65% of PIs lacked same as above mentioned and additionally about overdosing, effects on ability to drive and use in pregnancy and lactation. Remaining 4% PIs contained information only about Posology and drug administration, contraindications, special warnings and D-D interactions. Conclusions: The information provided by PIs in India is inadequate, only 5 among 100 complied to the regulation, and they may not serve as a reliable source of information. It is, therefore recommended for strict compliance of PIs with criteria mentioned in Indian Drugs and Cosmetics Act (1940) and Rules (1945), under section 1 of schedule Y. Increased awareness, regular audits, and national-level policy reinforcement are essential steps to make PIs a more effective tool in rational drug use.

Keywords

Introduction

DISCUSSION

To achieve safe and effective use of drugs, the prescribers have to be up-to-date with appropriate and accurate information regarding the medication.⁵ In India, the ratio of doctors to patients stands at 1:1700, whereas the recommended ratio is 1:1000.⁷ This disparity presents challenges for doctors to provide comprehensive information about medications, and for patients to retain such details. ⁶ So, a package insert acts as reliable source of information, for both prescribers and patients.  Efforts to enhance the content of package inserts are not only underway in India but also in other countries such as Europe, the USA, Australia, and Saudi Arabia.⁶ This study has noted a general enhancement in the completeness of the package inserts concerning therapeutic information. The percentage of inserts giving detailed information regarding the Posology and drug administered, contraindications and undesirable effects is respectively 100%, 99%, and 99% in comparison to 98%, 96%, and 97% respectively in the study conducted by Chhaya MU et al⁵ and 90%, 96% and 98% respectively in the Yuwnate AH et al⁶. The pharmaceutical information also seems to be improved like information about Excipients (55%), Incompatibilities (31%), Shelf life (34%) in comparison to 12%,19% and 16% respectively in the study conducted by Chhaya MU et al⁵ and Although the quality of package inserts has improved, there is scope for further improvements in therapeutic as well as pharmaceutical information. Many a times, package inserts for the same drug from different companies may have differing information. A post publishing surveillance to avoid such confusion would be beneficial.  Unfortunately, we noted that many pharmacies discard package inserts due to a lack of understanding of their significance, deeming them unnecessary bulk in packaging. Additionally, the widespread practice of dispensing drugs without prescriptions exacerbates this issue, resulting in patients missing out on valuable package inserts that could have provided essential information. The common practice of dispensing drugs without prescriptions means many patients never receive a PI at all. This undermines the utility of even well-crafted PIs. Although regulatory frameworks are well established under the Drugs and Cosmetics Act and Schedule Y, there remains a gap between regulation and enforcement. While manufacturers are legally obliged to update and standardize PIs, there is little oversight or penalty for non-compliance. Unlike the United States where FDA labeling reviews are mandatory for approval, in India, post-marketing audits are sporadic and often overlooked. Moreover, the lack of centralized PI repositories or publicly accessible databases hinders accountability. Bridging this gap would require coordinated efforts from the CDSCO, IPC, and medical colleges to initiate auditing, training, and educational outreach to ensure every stakeholder—from pharmaceutical companies to end-users—understands the importance of PI compliance.

5. To Enhance the Value of PIs:

• Regulatory audits by CDSCO should be conducted periodically.
• PIs should be made available in regional languages for patient accessibility.
• Digital PIs via QR codes could ensure access to the latest version.
• Pharmacists should be trained to provide and explain PIs during dispensing.
• Pharmaceutical companies must align local PIs with international quality benchmarks.

Limitations

The study focused exclusively on package inserts for orally administered and locally available drugs. If we included package inserts of topical and injectable drugs, it would give more detailed results.

Future-Scope
Future studies should include PIs of non-oral dosage forms like injectable, topical, and ophthalmic preparations to provide a more comprehensive overview. Further, comparative studies between different regions in India or across countries could offer insights into regulatory and compliance differences. Qualitative assessments of readability, language simplicity, and pictorial usage in PIs could also be valuable. Finally, evaluating the impact of updated PIs on patient outcomes and medication adherence would contribute significantly to public health policy.

CONCLUSION

In India, the information provided by Package Inserts (PIs) is often insufficient, with only 5 out of 100 meeting regulatory standards, making them potentially unreliable sources of information. It is, therefore recommended for strict compliance of PIs with criteria mentioned in Indian Drugs and Cosmetics Act (1940) and Rules (1945), under section 1 of schedule Y.

REFERENCES

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